[Federal Register Volume 75, Number 148 (Tuesday, August 3, 2010)]
[Notices]
[Page 45641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19043]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0181]
Guidance for Industry on Label Comprehension Studies for
Nonprescription Drug Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Label Comprehension
Studies for Nonprescription Drug Products.'' The guidance provides
recommendations on the design of label comprehension studies that can
be used to assess the extent to which consumers understand the
information conveyed by proposed nonprescription drug product labeling.
This guidance finalizes the draft guidance published on May 1, 2009.
DATES: Submit either electronic or written comments on agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Murewa Oguntimein, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5475,Silver Spring, MD 20993-0002, 301-
796-4869.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Label Comprehension Studies for Nonprescription Drug
Products.'' This guidance is intended for individuals or organizations
involved in the development of label comprehension studies for
nonprescription drug products. This guidance discusses general concepts
that should be considered in the design and conduct of a label
comprehension study. This guidance also incorporates advice obtained
from the September 25, 2006, meeting of the Nonprescription Drug
Advisory Committee that considered issues related to the analysis and
interpretation of consumer studies conducted to support marketing of
nonprescription drug products, and comments submitted to the draft
guidance published in the Federal Register of May 1, 2009 (74 FR
20322).
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on label comprehension studies for
nonprescription drug products. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19043 Filed 8-2-10; 8:45 am]
BILLING CODE 4160-01-S